Chronic urticaria, also referred to as chronic hives, is a condition characterized by the presence of recurrent, itchy, and inflamed wheals or hives that last longer than six weeks.

Unlike acute urticaria, which is short-lived, chronic urticaria can last for several months or even years. The condition may be accompanied by angioedema, a swelling of the skin’s deeper tissues, particularly around the eyes, lips, throat, and genitalia.

Chronic urticaria causes immense discomfort, both physically and emotionally, to patients and can significantly reduce their quality of life.

While the condition is generally not life-threatening, it can adversely impact a person’s mental health, relationships, and overall wellbeing. The exact cause of chronic urticaria remains unclear, but various factors such as genetics, autoimmune disorders, and environmental triggers can play a role.

The most common triggers of chronic urticaria include medications, insect bites, infections, and stress.

Existing Treatments for Chronic Urticaria

Treating chronic urticaria can be challenging since there is no one-size-fits-all approach. The condition is highly individualized, and therefore, treatment plans must be tailored to each patient’s unique needs.

For milder symptoms, over-the-counter antihistamines and corticosteroids can relieve itching and reduce inflammation. In more severe cases, patients may require stronger medications such as immunosuppressants.

However, despite the available treatment options, many patients continue to experience chronic urticaria symptoms, leaving them desperate for alternative treatments.

In recent years, there has been growing interest in biologic therapies for chronic urticaria, which target specific inflammatory molecules involved in the condition.

EU Positive Opinion on Omalizumab as a Treatment for Chronic Urticaria

Omalizumab, an anti-IgE monoclonal antibody, was originally developed as a treatment for severe asthma. However, in recent years, the drug has gained attention for its potential in treating chronic urticaria.

Omalizumab works by blocking the action of IgE, an antibody that plays a crucial role in allergic reactions, including chronic urticaria.

In January 2014, the European Medicines Agency (EMA) granted a positive opinion to omalizumab as a treatment for chronic urticaria in adults and adolescents aged 12 years and older who continue to experience symptoms despite antihistamine treatment.

The positive opinion was based on data from several clinical trials that showed omalizumab was effective in reducing symptoms and improving quality of life for chronic urticaria patients.

In one study, researchers randomly assigned 323 participants with refractory chronic urticaria to receive either omalizumab or placebo.

The study found that patients who received omalizumab had a significant reduction in urticaria activity scores and a higher rate of complete symptom control compared to those who received placebo.

How Omalizumab Works as a Treatment for Chronic Urticaria

As mentioned earlier, omalizumab works by blocking IgE, which plays a critical role in the development of chronic urticaria.

In many chronic urticaria patients, IgE antibodies attach to mast cells in the skin, triggering the release of histamine and other inflammatory substances that cause hives and itching.

Omalizumab binds to IgE antibodies, preventing them from attaching to mast cells. As a result, the release of histamine and other inflammatory mediators is reduced, leading to a decrease in urticaria symptoms.

How is Omalizumab Administered?

Omalizumab comes in the form of an injection that is administered every four weeks. The treatment is typically initiated in a healthcare setting, and patients can be trained to self-administer the injection at home after the first two doses.

Before treatment, patients must undergo a comprehensive evaluation to determine if they are a good candidate for omalizumab.

Since the drug suppresses the immune system, patients must be screened for infections, cancers, and if they have any other medical conditions that could potentially interact with the drug.

Common Side Effects of Omalizumab

Omalizumab is generally well-tolerated, with few significant side effects reported in clinical trials. The most common adverse effects of the drug include injection site reactions, such as pain, swelling, redness, itching, and bruising.

Patients may also experience headaches, nausea, diarrhea, and fatigue.

Serious side effects, such as anaphylaxis and severe allergic reactions, are rare but can occur. Patients must be closely monitored during the first dose and receive appropriate medical attention if a severe reaction occurs.

Conclusion

Chronic urticaria is a debilitating condition that can significantly impact a person’s quality of life. While different treatment options are available, many patients continue to suffer from the condition.

Omalizumab has shown promising results as a treatment for chronic urticaria in patients who have not responded to other treatments. It improves not only symptoms but also a patient’s quality of life.

However, as with any medication, omalizumab is not without side effects. Patients must receive appropriate medical evaluation before starting the treatment and be closely monitored for adverse reactions.

Further research is needed to determine the long-term safety and efficacy of omalizumab in the treatment of chronic urticaria.